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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score

Measure Description

QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.

Time Frame

Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values

Axitinib + Gemcitabine

Placebo + Gemcitabine

Participants Analyzed [Units: Participants]

314

316

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [Units: Units on a scale]Mean (Standard Deviation)

Pancreatic Pain: Baseline (n=246, 250)

41.6 (27.16)

40.0 (25.54)

Pancreatic Pain: Change at C2 D1 (n=191, 197)

-10.9 (24.38)

-10.1 (22.93)

Pancreatic Pain: Change at C3 D1 (n=141, 153)

-16.3 (25.51)

-11.2 (24.92)

Pancreatic Pain: Change at C4 D1 (n=99, 111)

-13.2 (28.70)

-11.4 (26.16)

Pancreatic Pain: Change at C5 D1 (n=67, 64)

-15.8 (28.06)

-13.0 (23.85)

Pancreatic Pain: Change at C6 D1 (n=41, 43)

-15.9 (25.47)

-13.0 (24.62)

Pancreatic Pain: Change at C7 D1 (n=25, 25)

-15.3 (28.02)

-15.0 (25.69)

Pancreatic Pain: Change at C8 D1 (n=11, 11)

-7.6 (27.76)

-9.8 (30.01)

Pancreatic Pain: Change at C9 D1 (n=6, 6)

-29.2 (31.06)

0.0 (15.81)

Pancreatic Pain: Change at C10 D1 (n=2, 3)

-20.9 (29.49)

5.6 (26.79)

Pancreatic Pain: Change at C11 D1 (n=1, 1)

0.0 [1]

0.0 [1]

Pancreatic Pain: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Pancreatic Pain: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Pancreatic Pain: Change at follow-up (n=47, 46)

-3.5 (29.59)

-3.6 (28.80)

Hepatic: Baseline (n=245, 254)

10.2 (17.21)

10.8 (17.59)

Hepatic: Change at C2 D1 (n=193, 205)

0.3 (18.24)

-2.0 (17.67)

Hepatic: Change at C3 D1 (n=142, 157)

-1.4 (16.78)

-2.5 (18.60)

Hepatic: Change at C4 D1 (n=99, 112)

-2.5 (18.34)

-2.4 (18.15)

Hepatic: Change at C5 D1 (n=68, 64)

1.0 (17.49)

-2.6 (16.60)

Hepatic: Change at C6 D1 (n=40, 41)

0.4 (15.34)

-3.2 (17.57)

Hepatic: Change at C7 D1 (n=25, 24)

-0.7 (16.30)

-4.9 (18.70)

Hepatic: Change at C8 D1 (n=11, 12)

-4.5 (13.10)

-4.2 (12.57)

Hepatic: Change at C9 D1 (n=6, 5)

-11.1 (13.60)

-13.3 (13.94)

Hepatic: Change at C10 D1 (n=2, 2)

-16.7 (23.55)

-8.4 (11.81)

Hepatic: Change at C11 D1 (n=1, 1)

0.0 [1]

0.0 [1]

Hepatic: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Hepatic: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Hepatic: Change at follow-up (n=47, 48)

2.8 (23.38)

-1.4 (23.27)

Digestive Symptom: Baseline (n=250, 255)

34.3 (30.78)

33.9 (31.05)

Digestive Symptom: Change at C2 D1 (n=195, 206)

2.8 (29.15)

0.6 (26.72)

Digestive Symptom: Change at C3 D1 (n=144, 159)

-1.2 (31.58)

-4.3 (32.97)

Digestive Symptom: Change at C4 D1 (n=100, 114)

0.5 (30.57)

-4.5 (30.90)

Digestive Symptom: Change at C5 D1 (n=69, 65)

1.4 (32.80)

-3.6 (36.14)

Digestive Symptom: Change at C6 D1 (n=40, 45)

3.3 (30.23)

0.4 (35.97)

Digestive Symptom: Change at C7 D1 (n=25, 26)

-6.0 (30.76)

-1.3 (24.91)

Digestive Symptom: Change at C8 D1 (n=11, 14)

4.5 (42.87)

17.9 (23.07)

Digestive Symptom: Change at C9 D1 (n=6, 6)

-13.9 (46.44)

22.2 (25.10)

Digestive Symptom: Change at C10 D1 (n=2, 3)

-33.3 (47.09)

11.1 (19.23)

Digestive Symptom: Change at C11 D1 (n=1, 1)

0.0 [1]

66.7 [1]

Digestive Symptom: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Digestive Symptom: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Digestive Symptom: Change at follow-up (n=47, 47)

6.0 (38.14)

2.8 (35.83)

Sexuality: Baseline (n=217, 232)

56.8 (36.90)

55.5 (38.04)

Sexuality: Change at C2 D1 (n=157, 181)

-0.5 (37.81)

-4.0 (33.17)

Sexuality: Change at C3 D1 (n=118, 139)

-4.9 (37.70)

-3.0 (32.25)

Sexuality: Change at C4 D1 (n=85, 100)

-4.1 (38.40)

3.0 (29.90)

Sexuality: Change at C5 D1 (n=55, 58)

-1.5 (34.30)

-5.2 (29.32)

Sexuality: Change at C6 D1 (n=30, 38)

12.2 (29.67)

-11.4 (33.58)

Sexuality: Change at C7 D1 (n=19, 21)

4.4 (35.06)

-7.1 (31.88)

Sexuality: Change at C8 D1 (n=8, 10)

12.5 (24.82)

-15.0 (26.59)

Sexuality: Change at C9 D1 (n=4, 6)

25.0 (31.93)

0.0 (23.55)

Sexuality: Change at C10 D1 (n=0, 3)

NA [2]

11.1 (19.28)

Sexuality: Change at C11 D1 (n=0, 1)

NA [2]

33.3 [1]

Sexuality: Change at C12 D1 (n=0, 0)

NA [2]

NA [2]

Sexuality: Change at C13 D1 (n=0, 0)

NA [2]

NA [2]

Sexuality: Change at follow-up (n=36, 41)

-3.2 (41.18)

-23.2 (42.31)

Health care(HC)satisfaction: Baseline (n=241, 247)

78.0 (26.66)

78.3 (23.94)

HC satisfaction: Change at C2 D1 (n=182, 194)

0.1 (27.73)

1.8 (24.13)

HC satisfaction: Change at C3 D1 (n=135, 149)

0.2 (31.54)

5.4 (24.98)

HC satisfaction: Change at C4 D1 (n=97, 108)

-4.3 (34.88)

-0.2 (26.52)

HC satisfaction: Change at C5 D1 (n=66, 59)

1.0 (29.66)

0.8 (28.77)

HC satisfaction: Change at C6 D1 (n=40, 39)

-6.7 (26.91)

-0.4 (27.96)

HC satisfaction: Change at C7 D1 (n=27, 20)

-4.3 (22.44)

6.7 (33.06)

HC satisfaction: Change at C8 D1 (n=12, 11)

-16.7 (52.23)

7.6 (20.22)

HC satisfaction: Change at C9 D1 (n=6, 6)

16.7 (47.14)

-5.6 (17.23)

HC satisfaction: Change at C10 D1 (n=2, 3)

-33.3 (0.0)

5.6 (9.64)

HC satisfaction: Change at C11 D1 (n=1, 1)

-33.3 [1]

0.0 [1]

HC satisfaction: Change at C12 D1 (n=1, 0)

-33.3 [1]

NA [2]

HC satisfaction: Change at C13 D1(n=1, 0)

-33.3 [1]

NA [2]

HC satisfaction: Change at follow-up (n=46, 45)

-0.7 (29.39)

-2.2 (31.50)

Body Image: Baseline (n=249, 251)

28.5 (28.46)

28.8 (28.67)

Body Image: Change at C2 D1 (n=189, 200)

4.9 (23.11)

-0.2 (26.78)

Body Image: Change at C3 D1 (n=142, 149)

4.9 (22.26)

2.1 (26.16)

Body Image: Change at C4 D1 (n=97, 111)

6.7 (26.20)

0.9 (26.48)

Body Image: Change at C5 D1 (n=70, 62)

4.8 (26.33)

-0.3 (25.87)

Body Image: Change at C6 D1 (n=40, 42)

8.3 (28.24)

-0.8 (33.92)

Body Image: Change at C7 D1 (n=25, 24)

12.0 (27.43)

-5.6 (33.22)

Body Image: Change at C8 D1 (n=11, 12)

21.2 (42.23)

11.1 (32.04)

Body Image: Change at C9 D1 (n=6, 6)

33.3 (52.69)

8.3 (46.87)

Body Image: Change at C10 D1 (n=2, 3)

-8.3 (11.74)

5.6 (78.77)

Body Image: Change at C11 D1 (n=1, 1)

0.0 [1]

-50.0 [1]

Body Image: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Body Image: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Body Image: Change at follow-up (n=47, 45)

13.1 (30.67)

11.5 (24.56)

Altered Bowel Habit: Baseline (n=250, 255)

20.3 (22.92)

21.2 (25.72)

Altered Bowel Habit: Change at C2 D1 (n=193, 204)

3.0 (24.19)

1.5 (22.21)

Altered Bowel Habit: Change at C3 D1 (n=143, 156)

6.2 (26.37)

2.5 (24.67)

Altered Bowel Habit: Change at C4 D1 (n=98, 114)

6.6 (25.52)

4.8 (22.14)

Altered Bowel Habit: Change at C5 D1 (n=68, 63)

8.3 (33.15)

1.3 (24.56)

Altered Bowel Habit: Change at C6 D1 (n=40, 43)

9.6 (30.63)

2.3 (28.07)

Altered Bowel Habit: Change at C7 D1 (n=25, 25)

6.0 (25.40)

1.3 (30.77)

Altered Bowel Habit: Change at C8 D1 (n=11, 13)

1.5 (29.29)

7.7 (38.86)

Altered Bowel Habit: Change at C9 D1 (n=6, 6)

13.9 (32.35)

-5.6 (51.27)

Altered Bowel Habit: Change at C10 D1 (n=2, 3)

-8.3 (35.36)

-16.7 (72.62)

Altered Bowel Habit: Change at C11 D1 (n=1, 1)

16.7 [1]

-100.0 [1]

Altered Bowel Habit: Change at C12 D1 (n=1, 0)

16.7 [1]

NA [2]

Altered Bowel Habit: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Altered Bowel Habit: Change at followup (n=47, 48)

6.0 (29.36)

5.9 (21.33)

Ascites: Baseline (n=250, 256)

38.7 (32.98)

32.9 (30.61)

Ascites: Change at C2 D1 (n=197, 207)

-8.6 (33.32)

-3.4 (29.65)

Ascites: Change at C3 D1 (n=144, 158)

-8.3 (33.34)

-5.1 (28.70)

Ascites: Change at C4 D1 (n=101, 114)

-5.0 (36.64)

-0.3 (26.05)

Ascites: Change at C5 D1 (n=71, 65)

-8.5 (34.15)

-0.5 (29.17)

Ascites: Change at C6 D1 (n=42, 45)

-3.2 (31.08)

-2.2 (32.10)

Ascites: Change at C7 D1 (n=26, 26)

-14.1 (32.91)

-12.8 (23.25)

Ascites: Change at C8 D1 (n=11, 14)

-18.2 (43.12)

-11.9 (28.05)

Ascites: Change at C9 D1 (n=6, 6)

-11.1 (34.42)

-16.7 (34.95)

Ascites: Change at C10 D1 (n=2, 3)

-16.7 (23.55)

22.2 (38.51)

Ascites: Change at C11 D1 (n=1, 1)

0.0 [1]

33.3 [1]

Ascites: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Ascites: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Ascites: Change at follow-up (n=48, 48)

5.6 (35.96)

-2.1 (26.11)

Indigestion: Baseline (n=252, 257)

29.4 (30.38)

24.0 (28.55)

Indigestion: Change at C2 D1 (n=198, 208)

-0.3 (26.87)

-2.4 (24.29)

Indigestion: Change at C3 D1 (n=144, 159)

0.2 (30.16)

-5.2 (25.59)

Indigestion: Change at C4 D1 (n=101, 115)

-4.0 (24.63)

-4.1 (25.80)

Indigestion: Change at C5 D1 (n=71, 65)

0.5 (29.01)

-4.6 (22.72)

Indigestion: Change at C6 D1 (n=41, 45)

1.6 (31.58)

-1.5 (24.57)

Indigestion: Change at C7 D1 (n=26, 26)

-3.8 (19.60)

-1.3 (17.59)

Indigestion: Change at C8 D1 (n=11, 14)

0.0 (21.06)

2.4 (20.53)

Indigestion: Change at C9 D1 (n=6, 6)

-5.6 (25.07)

11.1 (27.23)

Indigestion: Change at C10 D1 (n=2, 3)

-16.7 (23.55)

22.2 (19.23)

Indigestion: Change at C11 D1 (n=1, 1)

0.0 [1]

0.0 [1]

Indigestion: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Indigestion: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Indigestion: Change at follow-up (n=48, 48)

7.6 (30.94)

1.4 (30.73)

Flatulence: Baseline (n=249, 256)

37.9 (32.34)

34.0 (31.31)

Flatulence: Change at C2 D1 (n=197, 206)

1.2 (29.81)

2.6 (31.82)

Flatulence: Change at C3 D1 (n=146, 159)

3.2 (33.07)

0.2 (34.48)

Flatulence: Change at C4 D1 (n=101, 115)

-1.3 (33.65)

2.3 (32.07)

Flatulence: Change at C5 D1 (n=70, 65)

-1.0 (32.60)

1.0 (31.17)

Flatulence: Change at C6 D1 (n=41, 45)

-1.6 (26.83)

-1.5 (29.27)

Flatulence: Change at C7 D1 (n=25, 26)

-1.3 (26.31)

-3.8 (23.71)

Flatulence: Change at C8 D1 (n=10, 14)

-10.0 (35.34)

2.4 (27.62)

Flatulence: Change at C9 D1 (n=5, 6)

0.0 (0.00)

5.6 (13.59)

Flatulence: Change at C10 D1 (n=1, 3)

33.3 [1]

-11.1 (19.23)

Flatulence: Change at C11 D1 (n=0, 1)

NA [2]

0.0 [1]

Flatulence: Change at C12 D1 (n=0, 0)

NA [2]

NA [2]

Flatulence: Change at C13 D1 (n=0, 0)

NA [2]

NA [2]

Flatulence: Change at follow-up (n=48, 46)

-0.7 (35.41)

2.2 (34.00)

Cachexia: Baseline (n=251, 253)

33.1 (27.62)

33.6 (26.84)

Cachexia: Change at C2 D1 (n=197, 205)

4.2 (24.26)

0.6 (21.63)

Cachexia: Change at C3 D1 (n=145, 157)

4.6 (25.87)

-3.3 (21.13)

Cachexia: Change at C4 D1 (n=101, 112)

1.2 (26.37)

-6.2 (24.82)

Cachexia: Change at C5 D1 (n=70, 64)

0.5 (28.37)

-8.3 (24.48)

Cachexia: Change at C6 D1 (n=40, 44)

-2.1 (24.80)

-5.3 (24.84)

Cachexia: Change at C7 D1 (n=24, 26)

-0.7 (24.31)

-5.1 (25.27)

Cachexia: Change at C8 D1 (n=10, 14)

15.0 (34.64)

-4.7 (21.12)

Cachexia: Change at C9 D1 (n=5, 6)

16.7 (31.16)

2.8 (19.47)

Cachexia: Change at C10 D1 (n=1, 3)

0.0 [1]

0.0 (28.87)

Cachexia: Change at C11 D1 (n=0, 1)

NA [2]

-16.6 [1]

Cachexia: Change at C12 D1 (n=0, 0)

NA [2]

NA [2]

Cachexia: Change at C13 D1 (n=0, 0)

NA [2]

NA [2]

Cachexia: Change at follow-up (n=48, 47)

8.0 (31.69)

6.4 (30.79)

Side Effects: Baseline (n=209, 226)

24.9 (21.21)

27.4 (23.08)

Side Effects: Change at C2 D1 (n=159, 181)

11.2 (23.11)

5.8 (22.06)

Side Effects: Change at C3 D1 (n=113, 137)

13.0 (24.67)

4.7 (22.18)

Side Effects: Change at C4 D1 (n=80, 102)

10.1 (20.64)

4.9 (22.48)

Side Effects: Change at C5 D1 (n=54, 59)

7.4 (25.55)

3.6 (23.84)

Side Effects: Change at C6 D1 (n=29, 40)

8.1 (26.72)

-1.4 (25.32)

Side Effects: Change at C7 D1 (n=17, 22)

15.0 (20.77)

-1.0 (19.38)

Side Effects: Change at C8 D1 (n=8, 11)

9.7 (19.19)

-3.0 (22.83)

Side Effects: Change at C9 D1 (n=3, 6)

14.8 (23.15)

-1.9 (27.60)

Side Effects: Change at C10 D1 (n=0, 3)

NA [2]

0.0 (40.12)

Side Effects: Change at C11 D1 (n=0, 1)

NA [2]

-33.4 [1]

Side Effects: Change at C12 D1 (n=0, 0)

NA [2]

NA [2]

Side Effects: Change at C13 D1 (n=0, 0)

NA [2]

NA [2]

Side Effects: Change at follow-up (n=42, 42)

18.8 (24.37)

13.2 (27.80)

Fear of Future Health (FH): Baseline (n=252, 250))

59.3 (31.33)

61.1 (33.07)

Fear of FH: Change at C2 D1 (n=192, 201)

-3.5 (31.82)

-9.6 (28.80)

Fear of FH: Change at C3 D1 (n=145, 155)

-0.9 (34.02)

-11.6 (30.07)

Fear of FH: Change at C4 D1 (n=103, 113)

-4.5 (32.70)

-15.9 (30.90)

Fear of FH: Change at C5 D1 (n=71, 64)

-0.5 (31.12)

-10.9 (29.74)

Fear of FH: Change at C6 D1 (n=42, 44)

-4.8 (30.86)

-14.4 (32.47)

Fear of FH: Change at C7 D1 (n=27, 25)

-6.2 (22.72)

-13.3 (33.34)

Fear of FH: Change at C8 D1 (n=12, 12)

2.8 (30.02)

5.6 (27.84)

Fear of FH: Change at C9 D1 (n=6, 6)

16.7 (27.90)

16.7 (34.96)

Fear of FH: Change at C10 D1 (n=2, 3)

-16.7 (23.62)

11.1 (50.96)

Fear of FH: Change at C11 D1 (n=1, 1)

0.0 [1]

0.0 [1]

Fear of FH: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Fear of FH: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Fear of FH:Change at follow-up (n=48, 45)

5.6 (28.63)

-4.4 (38.67)

Future Plan ability: Baseline (n=250, 249)

34.3 (33.59)

38.0 (34.40)

Future Plan ability: Change at C2 D1 (n=192, 198)

6.1 (38.19)

-0.3 (34.58)

Future Plan ability:Change at C3 D1 (n=142, 153)

3.5 (39.65)

0.4 (36.68)

Future Plan ability:Change at C4 D1 (n=101, 112)

5.6 (36.55)

0.3 (37.04)

Future Plan ability:Change at C5 D1 (n=70, 62)

0.9 (34.05)

-3.8 (39.17)

Future Plan ability:Change at C6 D1 (n=42, 42)

4.8 (34.99)

0.8 (46.27)

Future Plan ability: Change at C7 D1 (n=26, 24)

2.6 (28.18)

-7.0 (36.76)

Future Plan ability: Change at C8 D1 (n=11, 11)

6.1 (32.74)

3.0 (43.36)

Future Plan ability: Change at C9 D1 (n=5, 6)

0.0 (23.55)

0.0 (55.78)

Future Plan ability: Change at C10 D1 (n=1, 3)

0.0 [1]

-11.1 (69.43)

Future Plan ability: Change at C11 D1 (n=1, 1)

0.0 [1]

-66.7 [1]

Future Plan ability: Change at C12 D1 (n=1, 0)

0.0 [1]

NA [2]

Future Plan ability: Change at C13 D1 (n=1, 0)

0.0 [1]

NA [2]

Future Plan ability: Change at followup (n=48, 45)

21.5 (35.40)

5.2 (38.25)

[1]

Standard deviation was not estimable since only one participant was evaluable.

[2]

Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score

7. Secondary:

Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]